Includes a production room and a laboratory under negative pressure
Telstar has completed the construction and installation of a modular R+D laboratory and kilo lab at the Medichem production centre in Hal Far, Malta for the manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).
The facility consists of a production room and a laboratory, both under negative pressure relative to adjacent rooms and the exterior to ensure user protection.
Telstar carried out the project management of the facility under an EPC (Engineering, Procurement and Construction) arrangement. The architecture, HVAC system, distribution of utilities and services, the provision of heating and cooling water, and the inside furnishings were included in the scope of this project. Telstar undertook the construction engineering phases, which relied on direct client involvement, the purchasing of materials and the construction, which required continuous supervision of materials quality and workmanship to achieve approval and validation of the facility.
The modular laboratory is a single structure that comprises nine rooms grouped in four areas: a production area, which includes two 15-litre reactors, a filter dryer and a microniser; an R+D laboratory; a technical area (to house the air handling unit, hydraulic installation, electrical and control cabinets, vacuum system, etc.) and staff changing rooms for entry and exit.
The modular approach enabled the entire system to be assembled and qualified in the Telstar manufacturing facility in Estonia
The HPAPIs will be produced in a GMP environment and with containment levels of 40ng/m3.
The modular approach enabled the entire system to be assembled and qualified in the Telstar manufacturing facility in Estonia. From the operational standpoint, this had advantages in terms of availability, control and access to construction materials and manpower without relying heavily on the supply capacity in Malta. It has also resulted in considerable cost savings as a consequence of the limited time staff spent travelling in addition to reducing implementation time on site.
The modular facility was installed, commissioned and validated in its final location at the Medichem premises in Malta within one month. Telstar says if conventional construction techniques had been used it would have taken six months to complete. Since the facility is modular, Medichem can modify it and even relocate it if required in the future.
The laboratory fulfils the high containment and maximum safety specifications required when operators handle highly active ingredients. For example, air extraction from the rooms uses Bag-In/Bag-Out (BIBO) safe change filters to eliminate the risk of cross-contamination and to protect the operator during filter changes. An emergency shower has also been provided at the exit, which the operator can use in the event of a hazardous spill.
In addition, the kilo lab ATEX 3G classification for all the equipment in the room (including switches, push buttons, light fixture, power outlets, etc.) protects against explosions that are a risk when flammable solvents are being processed.
Finally, Telstar has included an innovative system for distributing breathable air. Breathable air connection points have been installed in all the rooms so that, in the event of an emergency, the operator has access to a safe supply of air stored in cylinders placed outside the module.
Medichem is an independently-owned API manufacturer, headquartered in Barcelona, Spain with more than 40 years of experience in this market. The company, which has two FDA inspected plants (Spain and Malta) and three R&D centres located in Spain, Malta and China, has more than 250 people working at various locations (Spain, Malta and China) and delivers products to more than 60 countries (US, the European Union and Japan, among others).
Medichem has a sister company, Combino Pharm, which manufactures, develops and markets generic pharmaceutical products. Both companies also offer contract manufacturing services (API and FDF).